Hong Kong — Ascletis Pharma Inc. announced that the first participant has been dosed in its global Phase 3 clinical program evaluating ASC30, an investigational once-daily oral small-molecule GLP-1 receptor agonist for chronic weight management.
The program includes two pivotal trials, AURORA-1 and AURORA-2, which are expected to enroll about 4,600 adults with obesity or overweight across sites in the United States, Europe and Canada.
ASC30 is being developed as an oral treatment for chronic weight management and diabetes. The two Phase 3 studies will evaluate three maintenance doses — 20 mg, 40 mg and 60 mg — over 72 weeks.
AURORA-1 will enroll adults with obesity or overweight and at least one weight-related comorbidity, excluding those with type 2 diabetes. AURORA-2 will enroll adults with obesity or overweight who also have type 2 diabetes.
The primary endpoint in both trials is the percentage change in body weight from baseline to Week 72.
“Obesity is a complex, chronic disease associated with over 200 comorbidities and represents an immense global public health burden. While injectable incretin therapies have transformed obesity care, there remains substantial unmet need for an oral small molecule that is effective, well-tolerated, and convenient enough to expand patient access and support long-term adherence,” said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis.
“Dosing the first participant in our AURORA global Phase III clinical program marks a transformative milestone for Ascletis. ASC30 enters this pivotal stage backed by a competitive Phase II weight loss profile, favorable gastrointestinal tolerability, and no observed hepatic safety signals.”
Ascletis expects topline data from the Phase 3 program in the third quarter of 2028. The company plans to submit a New Drug Application to the U.S. Food and Drug Administration by the end of 2028 and a Marketing Authorisation Application to the European Medicines Agency in early 2029.
The company said it has sufficient cash to fund operations into 2029 and through its planned U.S. and European regulatory submissions.
Ascletis is also developing additional oral small-molecule obesity treatments, including fixed-dose combinations targeting GLP-1/GIP, GLP-1/GIP/amylin and GLP-1/amylin pathways.
